Systems and methods for intubation

ABSTRACT

An intubation device is provided. An intubation device comprises a movable guide configured to guide an insertion of an endotracheal tube into a trachea of a patient, the guide having a guide extension and a guide tip; an external trachea identifier source external to the trachea and disposed on the patient during an intubation, wherein the trachea identifier source generates and transmits a signal; at least one trachea condition sensor disposed on the guide tip to detect the signal generated by the trachea identifier source; and a guide control device operatively coupled to the guide, the guide control device configured to move the guide into the trachea in response to the detected signal.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to and is a divisional application ofU.S. patent application Ser. No. 11/893,536, titled “Systems and Methodsfor Intubation” and filed on Aug. 15, 2007, the entirety of which ishereby incorporated herein by reference.

TECHNICAL FIELD

The present disclosure relates generally to systems and methods tointubate a patient, and more particularly to systems and methods tointubate a patient as guided by one or more trachea condition sensors.

BACKGROUND

Some medical procedures are invasive and potentially dangerous althoughthey are necessary life-saving procedures. Intubation, specificallytracheal intubation, is typically performed at various medicalconditions, such as application of general anesthesia, comatose, etc.Tracheal intubation involves the placement or the insertion of anendotracheal tube (ETT) into a patient's trachea to protect thepatient's airway and provide a means of mechanical ventilation. Delayand/or misplacement of the endotracheal tube, such as misplacement ofthe endotracheal tube into esophagus, may cause permanent neurologicaldamage or death. Malposition of the ETT may jeopardize airway protectionor cause inadequate ventilation. It is therefore imperative to intubatea patient quickly and position the ETT correctly when a medicalcondition arises.

Various technologies have been developed to assist the placement of theendotracheal tube into the trachea. In a technique called directlaryngoscopy, a laryngoscope is used to obtain a direct view of theglottis and the endotracheal tube is then inserted to pass through themouth, larynx, and vocal cords into the trachea under direct vision.Another technique uses flexible fiberoptic bronchoscopes to obtainindirect view of epiglottis and vocal cord through coated glass fiber tofacilitate intubation. A recent technology, a video laryngoscope,incorporates a video camera at a tip of modified laryngoscope to furtherassist the visual verification of ETT placement.

The above technologies heavily rely on visual observation and theexperience of the user. Despite the improved visibility by varioustechniques and extensive training, failed intubation occurs frequently.Further, intubation under direct or indirect visual observation is notalways possible in clinical practice. For example, visual verificationmay be impossible under some medical conditions, such as unstablecervical spine, airway trauma, heavy airway secretion, bleeding, etc.

While intubation is frequently performed by highly trained medicalprofessionals in a hospital setting, such as an emergency room,operation room, or intensive care unit, etc., it is also performed byparamedics or equivalent in non-hospital settings, such as battlefields,motor vehicle accident scenes, or various field medical emergencies.Lack of experienced medical professionals and lack of easily-operatedintubation devices may make the life-saving procedure difficult withpotential loss of life in both hospital settings and non-hospitalsettings.

SUMMARY

The inventor herein has recognized that it may be desirable to have aneasily operated intubation device that can intubate a patient withoutsolely depending on visual aids for the intubation. A system and methodis provided for intubating a patient manually, semi-automatically orautomatically via feedback from a trachea condition sensor. According toone aspect, an intubation device comprises a movable guide configured toguide an insertion of an endotracheal tube into a trachea of a patient,the guide having a guide extension and a guide tip; an external tracheaidentifier source external to the trachea and disposed on the patientduring an intubation, wherein the trachea identifier source generatesand transmits a signal; at least one trachea condition sensor disposedon the guide tip to detect the signal generated by the tracheaidentifier source; and a guide control device operatively coupled to theguide, the guide control device configured to move the guide into thetrachea in response to the detected signal.

According to another aspect, an intubation device comprises a movableguide configured to guide an insertion of an endotracheal tube into atrachea of a patient, the movable guide having a guide extension and aguide tip; an external trachea identifier source disposed external tothe trachea and on a body of the patient during an intubation, whereinthe trachea identifier source generates a signal and transmits thesignal toward the trachea; at least one trachea condition sensordisposed on the guide tip to detect the signal generated and transmittedby the trachea identifier source; and a guide control device operativelycoupled to the guide and communicatively linked to the trachea conditionsensor, the guide control device configured to process a detected signalfrom the trachea condition sensor to determine an opening of the tracheaand direct an insertion of the guide into the trachea in response to thedetected signal.

According to another aspect, a method of intubating a patient using anintubation device is provided. The intubation device includes a guide,at least one trachea condition sensor on a tip of the guide, and a guidecontrol device configured to move the guide. The method comprisesdisposing an external trachea identifier source in a location externalto a trachea of the patient; detecting signals transmitted from theexternal trachea identifier source using the trachea condition sensor;processing real time information from the detected signal of the tracheacondition sensor to determine an opening of the trachea; and moving theguide in response to the processed real time information.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a schematic view of an intubation device as used tointubate a patient.

FIG. 2 is a perspective view of the intubation device of FIG. 1according to an embodiment of the present disclosure.

FIG. 3 is a schematic view of the intubation device of FIG. 1 as used tointubate a patient, illustrating trachea conditions and tracheaidentifier sources to generate trachea conditions.

FIG. 4 is a schematic diagram of the intubation device of FIG. 1,illustrating example components of the intubation device.

FIG. 5 is a flowchart illustrating an example method of intubating apatient automatically or semi-automatically using an intubation deviceaccording to an embodiment of the present disclosure.

FIG. 6 is a schematic illustration of an example user interface of anembodiment of the intubation device of FIG. 1 according to the presentdisclosure.

FIG. 7 is a schematic illustration of guide motions in response to atrachea condition.

FIG. 8 is an exploded front view of a guide tip of an intubation deviceaccording to another embodiment of the present disclosure.

FIG. 9 shows a schematic view of a guide of an intubation deviceaccording to another embodiment of the present disclosure.

FIG. 10 illustrates another embodiment of an intubation device accordingto the present disclosure.

FIG. 11 is an exploded view of a guide tip of the intubation device ofFIG. 10.

DETAILED DESCRIPTION

As described in more detail below, an intubation device of the presentdisclosure can correctly intubate a patient with or without visualassistants. For example, in some embodiments, the intubation device maycomprise an intubation guide, a guide control system, an informationprocessing center, and various accessories, such as a digital videosystem, a medication delivery system, a medical instrument conduit, aremote control module, etc. In some embodiments, an intubation guide maycomprise an airway-specific sensor that can process real time tracheaairway information continuously; a direction-seeking guide tipconfigured to react to the sensed and processed airway information; anda guide body that can extend and retract in response to sensed andprocessed airway information. In some embodiments, the intubation devicemay include a build-in digital video camera and conduits within theguide. In this way, the intubation device can have visual confirmationcapability, medication delivery functionality and instrument insertionflexibility during the intubation.

FIG. 1 shows a schematic view of an example intubation device 10 inaccordance with the present disclosure as used to intubate a patient.Intubation device 10 may include a guide 12 and a guide control device14. Guide 12 may be adapted to pass through the patient mouth 20, vocalcord 22, and insert into trachea 24. Guide control device 14 may beconfigured to direct an insertion of guide 12. In some embodiments,guide device 14 may be configured for directional control of a guide tipand extension and/or retraction of a guide body in response to tracheaairway information received from a trachea condition sensor or inresponse to the user's clinical decision. When it is determined thatguide 12 is in trachea 24, an endotracheal tube 26 may be moved overguide 12 and into trachea 24. Then, guide 12 may be removed from trachea24. Endotracheal tube 26 may remain in trachea 24.

FIG. 1 also illustrates possible paths during the guide placement. Asshown in FIG. 1, epiglottis 28 and glottis 30 are in the front of vocalcord 22. Esophagus 32 is under trachea 24. Trachea is located anteriorto esophagus 32. Trachea is an open tube-like cartilage structure whileesophagus is normally collapsed in the absence of swallowing. Twocavities, trachea 24 and esophagus 32, are adjacent each other. Thus,guide 12 may be inserted into either trachea 24 or esophagus 32. Asdescribed below, intubation device 10 is configured to prevent the guideor tube being inserted into esophagus 32.

For example, intubation device 10 is configured to direct guide 12 intotrachea 24 correctly based on at least one trachea condition. Thetrachea condition may be detected by a trachea condition sensor disposedon guide 12. In some embodiments, the trachea condition may be a uniquenatural or existing condition in trachea 24 including but are notlimited to carbon dioxide (CO₂), oxygen, nitrogen, or air flow, etc. Insome embodiments, the trachea condition may also be an artificial orintroduced condition that is configured to distinguish trachea 24 fromesophagus 32. The introduced trachea condition may include an introducedcompound. The compound may be breathed, swallowed, drank or injected tothe patient and then can be exhale via the lungs and the trachea. Insome embodiments, the trachea condition may be a signal conditiongenerated by a trachea identifier source. For example, the signal mayinclude light, sound, magnetic field, electricity, etc. Tracheaconditions will be described in detail below.

Intubation device 10 enables directional movements as well as advancingand withdrawing movement during insertion of guide 12 into trachea 24 inresponse to the detected trachea condition. In this way, intubation maybe performed “blindly” without or with visual verification.

In addition, intubation device 10 may also be used as a confirmationdevice for correct ETT placement and proper position. For example,confirmation may be needed in certain circumstances, such as doublelumen ETT placement and position, bronchial blocker placement andposition, ETT exchange or after any suspected ventilation problems. Insuch circumstances, guide 12 may be reinserted into trachea 24 throughendotracheal tube 26. Proper placement of endotracheal tube 26 may bereconfirmed by information from the trachea condition sensor. In someembodiments, the placement of endotracheal tube 26 may further bereconfirmed by a video image captured by a video camera on guide 12.Alternatively, confirmation of proper placement may be also performed byknown methods, such as direct laryngoscopy, fiberoptic bronchoscopy,chest auscultation, and carbon dioxide detection.

FIG. 2 is a perspective view of an embodiment of the intubation device10 in FIG. 1 according to the present disclosure. As shown in FIG. 2,intubation device 10 may comprise a guide 12, a guide control device 14,and at least one of trachea condition sensors 34 a, 34 b, 34 c, 34 ddisposed on guide 12. In the depicted embodiment, guide 12 may include aguide extension 16 and a guide tip 18. Guide control device 14 may beconfigured to drive guide 12 in all directions into trachea 24 inresponse to detected trachea conditions in any suitable manner. Forexample, guide 12 may be inserted into the trachea manually,semi-automatically or automatically in response to information from thetrachea condition sensors. Additionally, or alternatively, controldevice 14 may be configured to override the automated guide movements ata user's discretion.

Trachea condition sensors, 34 a, 34 b, 34 c, 34 d may be configured todetect trachea conditions. As described above and will be described indetail below, a trachea condition may be any condition thatdistinguishes the trachea from the esophagus. Information from thetrachea condition sensor may assist correct insertion of guide 12 and/orconfirm placement of endotracheal tube 26.

In the depicted embodiment, trachea condition sensors 34 a and 34 b aredisposed on an end of guide tip 18, trachea conditions sensor 34 c isdisposed on a side of guide tip 18, and trachea condition sensor 34 d isdisposed on a side of guide extension 16. It should be appreciated thatthe trachea condition sensor may be disposed on any suitable position ofguide 12 to detect the trachea condition and generate a reliableinformation that distinguishes the trachea from the esophagus.

While four trachea sensors are shown in FIG. 2, it should be appreciatedthat any number of trachea condition sensors may be used. For example,only one trachea condition sensor may be disposed on guide 12. As analternative, guide 12 may include two or three trachea conditionsensors. As another alternative, more than four trachea conditionsensors may be employed in an intubation device.

Further, any combination of trachea condition sensors may be used. Forexample, sensors 34 a and 34 b may detect existing trachea conditions,sensor 34 c may detect introduced trachea conditions, and sensor 34 dmay detect signal trachea conditions. Alternatively, selected sensorsmay detect the same trachea condition at different levels. For example,trachea condition sensors 34 a and 34 b may be CO₂ sensors that detectCO₂ at different concentration levels, trachea condition sensor 34 c maybe a pressure sensor or a flow rate sensor, and trachea condition sensor34 d may be a light sensor.

Continuing with FIG. 2, guide 12 may be made from flexible,semi-flexible or rigid materials. In some embodiments, guide 12 may beconfigured to be in a form similar to intubation stylets known in theart. However, it should be appreciated that guide 12 may be formed inother configurations. While guide 12 may comprise guide extension 16 andguide tip 18 as two portions as shown in FIG. 2, guide 12 may be formedas an integrated part. Further, guide extension 16 and guide tip 18 maybe made from the same material or different materials.

Further, guide 12 may assume any suitable configuration adapted for anautomated or semi-automated intubation device or a manual insertionfollowing information from the trachea condition sensors. For example,guide 12 may be configured to be moved semi-automatically, i.e., movedthrough activation of movement control actuators by a user or to bemoved automatically, i.e., moved through execution of a software programstored in the guide control device 14. In one example, guide movementsmay include motions of guide tip 18 in all directions in response todetected trachea conditions and motions of guide extension 16 to followthe guide tip 18. In some embodiments, to facilitate the guide movement,guide 12 may include a plurality of flexible cords 36. Alternatively,guide 12 may include a single cord or a backbone to facilitate itsmovements instead of a plurality of cords 36. Guide 12 may also includeguide actuator 38 that enables the desired movements as describedherein. While guide actuator 38 is shown to be disposed on guide 12,guide actuator 38 may also be disposed in a house of guide controldevice 14 or in any suitable locations. It should be noted that guide 12may include any suitable feature that enables the desired movements andguide 12 may be adapted to any specific mechanism that moves the guide.

Additionally, intubation device 10 may include a set of varying sizedguides adapted to fit various types of patients, such as adults andchildren. Guide 12 may be detachably coupled to control device 14 by acoupler, such that guide 12 may be changed to fit for the requirementsfor different patients.

Further, it should be appreciated that guide 12 may be configured to beused as an endotracheal tube. For example, guide 12 may include a hollowtube. As the guide 12 is inserted into the trachea, guide 12 may bedetached from guide control device 14 and remain in trachea 24 toprovide required airway management.

To operate intubation device 10, a user interface 40 may be included. Insome embodiments, user interface 40 may include a display to presentinformation, such as intubation data. The information or intubation datamay include indicia, such as level, intensity, or patterns of a tracheacondition. In a manually-operated intubation device, a user may insertguide 12 and adjust its positions according to the displayed tracheaconditions. In some embodiments, user interface 40 may include a userinput device such as actuators configured to activate automatedmovements of the guide. For example, in a semi-automatic intubationdevice, the user may activate appropriate actuators to move the guide incorresponding directions based on displayed trachea conditions. In anautomatic intubation device, activation of one or more actuators mayinitiate the guide insertion and perform the intubation automatically.Relevant information may also be displayed on user interface 40 toenable monitoring and/or controlling of the intubation process. Itshould be appreciated that the user interface may be configured toinclude one or more displays in any suitable manner to accommodatespecific operating mechanisms of intubation device 10.

Additionally, or alternatively, intubation device 10 may also include amultiple function port 42 configured to administrate medicines to thepatient as guide 12 moves into the trachea. As an example, the medicinemay include local anesthetics, inhalation anesthetics, O₂ orbronchodilators. Alternatively, the multiple function port 42 can beused as a conduit for instruments to perform tissue biopsy, lasertreatment and other diagnostic or therapeutic procedures.

Further, intubation device 10 may include a power supply 44 thatprovides power required by the electronic and/or mechanical componentsof the intubation device. In some embodiments, power may be suppliedfrom an external power source, such as an AC outlet or external powersource or combination of the two power sources. Alternatively, powersupply 44 may include one or more batteries in a battery compartment ofpower supply 44. As yet another alternative, power supply 44 may includea solar cell configured to gather energy from ambient light.

FIG. 3 is a schematic view of intubation device 10 as used to intubate apatient, illustrating trachea conditions and trachea identifier sourcesthat generate trachea conditions. Trachea conditions may include anyidentifiable characteristic that differentiates trachea 24 fromesophagus 32 because the characteristic is either only present in thetrachea or is present in different magnitudes or patterns in the tracheaand the esophagus. As shown in FIG. 3, example trachea conditions 80 mayinclude, but are not limited to CO₂, oxygen (O₂), nitrogen (N₂), helium,air flow, positive or negative pressure, pressure change, air flow,inhalation anesthetics (e.g., desflurane, isoflurane, sevoflurane),Xenon, nitrous oxide (N₂O), sound including ultrasound, alcohol,isotope, light, magnet, and electricity, etc.

As described above, a trachea condition or trachea-specific conditionmay include an existing trachea condition that differentiates tracheafrom esophagus. The existing trachea condition may includecharacteristics naturally existing in the trachea. In some embodiments,the existing trachea condition may be considered as natural tracheacondition. For example, CO₂ is exhaled from the lungs and is naturallypresent in the trachea but is absent from the esophagus. Thus, thetrachea condition may be CO₂ and a trachea condition sensor may be a CO₂sensor configured to detect the presence of CO₂. In some embodiments,the CO₂ sensor may be configured to detect CO₂ concentrations at orabove an atmospheric level. It should be appreciated that the CO₂ sensormay be any suitable CO₂ sensor that can detect CO₂ qualitatively orquantitatively and can respond to the CO₂ concentration variations orCO₂ gradients quickly.

Similarly, oxygen and nitrogen exist naturally in the trachea. Thus, thetrachea condition may be oxygen or nitrogen and the trachea sensor maybe an oxygen sensor or a nitrogen sensor.

In another example, air flow in the trachea may be a unique identifierof the trachea to distinguish the trachea from the esophagus. Thetrachea condition may be airflow and air pressure. The trachea conditionsensor may be a flow rate meter that measures air movement or amount ofair in the trachea. The trachea condition sensor may also be a pressuresensor that measures the pressure or pressure changes in the trachea. Insome embodiments, as an example, an automatic intubation device for aspontaneous ventilation patient may be configured in such a manner thata patient's respiratory movement initiates and guides the insertion ofguide 12 in response to an intensified signal from air flow or pressuresensors. It should be noted that an air flow rate meter and a pressuresensor may be any suitable sensor that can detect the desired levels ofair flow and air pressure (either positive or negative pressure).

In yet another example, an existing trachea condition may be sound inthe trachea generated by the air movement, air turbulence and phonation(vocal cord is the beginning of the trachea). Thus, any suitable soundsensor may be used as a trachea condition sensor.

In addition, the trachea condition may be an introduced or artificialcondition foreign to the trachea. For example, a compound or a tracermay be introduced into the patient by inhalation, digestion orinjection. Exhaling the compound or the tracer from the lungs may createa trachea-specific condition. As an example, the compound may includeintravenous alcohol, helium, inhalation anesthetics, Xenon, or N₂O, etc.The trachea condition sensor or compound detecting sensor may include asensor to detect the presence and concentration of one or more suchcompounds or tracers.

In another example, an introduced compound may be spiked with a traceamount of an isotope, such as H₃O. The isotope may be detected by anisotope sensor.

It should be noted that the introduced tracer may be any suitablecompound or substance that can be introduced to the patient and itspresence in the trachea or around the entry point to the trachea isdetectable by a sensor. The substance may be in a state of gas, liquid,or solid. The compound may have minimum side effect to the patient.

In addition to the existing and introduced trachea conditions, a thirdtype of trachea condition may be a signal trachea condition. In someembodiments, the signal trachea condition may be a detectable signal ortrachea identifier generated by a trachea identifier source 82. Becauseof different anatomical locations of trachea 24 and esophagus 32(trachea 24 is located anterior to esophagus 32) and different geometricstructures around entries to the trachea and the esophagus (the tracheais an open tube-like cartilage structure verse esophagus which isnormally collapsed in the absence of swallowing). The signal transmittedto the trachea or around the trachea may have different intensities orpatterns than those in the esophagus. Thus, detected signal may provideinformation that distinguishes the trachea from the esophagus. In someembodiments, the trachea identifier may be in a form of energy. In oneexample, trachea identifier source 82 may be a light source. Tracheaidentifier source 82 may be configured to generate any suitable light,such as visible light, ultraviolet, infrared, laser, etc. Tracheaidentifier source 82 may also include light emitting diodes (LEDs). Thetrachea condition sensor may be a light sensor.

In another example, trachea identifier source 82 may include a sounddevice to generate sound. The sound device may be configured to createand send sound in any suitable decibel level to trachea 24. For example,the sound may be audible sound and ultrasound. The trachea conditionsensor may be a sound detector.

In yet another example, trachea identifier source 82 may comprise amagnetic source configured to generate a magnetic field in trachea 24.The magnetic source may include any suitable source, such as a permanentmagnet or electric magnet. The trachea sensor may be a magnetic sensor.

In still another example, an electrode pair may generate a detectableelectric signal. For example, trachea identifier source 82 may include afirst electrode that forms an electrical cell together with a secondelectrode disposed on guide 12. An electrical signal may be generatedwhen both first electrode and second electrode are in contact with thepatient's body. A specific range of electrical impedance may exist whenguide 12 contacts trachea 24. The range may distinguish trachea 24 fromesophagus 32. Thus, it is possible to identify trachea 24 by ameasurement of electric signals, such as a voltage or a currentgenerated in the cell. It should be appreciated that, in someembodiments, the first electrode on guide 12 may be employed as atrachea condition sensor.

Continuing with FIG. 3, trachea identifier source 82 may be disposed ina position that is adjacent to trachea 24. In some embodiments, tracheaidentifier source 82 may be disposed on the patient's neck 84 abovetrachea 24. In some embodiments, trachea identifier source 82 may bedisposed inside the patient body and adjacent to trachea 24. Forexample, trachea identifier source 82 may be mounted on a needle-likestructure 81 and embedded into neck 84 during the intubation.

Alternatively, trachea identifier source 82 may be disposed on guide 12.As guide 12 is inserted into the trachea, the signal or the tracheaidentifier transmitted to trachea 24 may be different from the signaltransmitted to esophagus 32 when guide 12 is inserted into esophagus 32,thus distinguishing the trachea from the esophagus.

FIG. 3 also shows an alternative embodiment of intubation device 10. Asshown in FIG. 3, intubation device 10 may be connected to a network 88.Intubation device 10 may be configured to connect to network 88 andenable commutations with a plurality of computing devices 90. Computingdevice 90 may be located remotely to a location where an intubation isperformed. Intubation device 10 and computing device 90 may be connectedto the network 88 through wire or wireless connections.

Connections between intubation device 10 and computing device 90 allowthe intubation to be monitored and controlled remotely. For example,information on operations of intubation device 10, i.e., intubation data(e.g., detected trachea conditions, positions of guide, etc.) may besent to computing device 90. In turn, a user of intubation device 10 mayreceive instructions from network 88. In this way, the intubation may bemonitored, controlled and/or supervised. Communications between theintubation device and network may be useful when the intubation isperformed at non-hospital settings, such as emergency sites orbattlefields or when the intubation is performed by less-trainedpersonnel. For example, the intubation may be performed at an emergencysite and may be monitored by a doctor at a hospital. In another example,the intubation may be performed at one location and may be supervised bya person using computing device 90 at the same location. Moreover, auser may use computing device 90 to operate and control the intubationremotely. In one embodiment, computing device 90 may function as guidecontrol device 14 to perform various operations, such as control guidemovements, etc, i.e., enable control of guide control device 14. Forexample, the intubation may be initiated at one location and may beperformed by a doctor in another location.

FIG. 4 is a schematic diagram of intubation device 10, illustratingexample components of the intubation device. As illustrated in FIG. 4,guide control device 14 may include a user interface 40 and a controller50. User interface 40 may include a user input device 52 to activate andoperate intubation device 10. Further, user interface 40 may include adisplay 54 to present information on an operation of intubation device,such as intubation data (e.g., detected trachea conditions, etc.).Display 54 may also be presented on one or more networked computingdevices 90 as described in regards to FIG. 3.

Controller 50 may include a processor 56, a memory 58, and acommunication interface 60. Processor 56 and communication interface 60may be linked by a bus to memory 58. Controller 50 may also beconfigured to communicate with trachea condition sensor 34 viacommunication interface 60. In some embodiments, memory 58 may includeboth non-volatile and volatile memory, and programs or algorithms may bestored in non-volatile memory and executed by the processor usingportions of volatile memory to accomplish the operations describedherein.

In some embodiments, the intubation may be performed manually. Asdescribed above, trachea condition sensor 34 may be disposed on guide12. When intubation device 10 is activated, a user may insert guide 12into the patient's mouth or nose and then adjust a position of guide 12based on displayed trachea condition information (e.g., on display 54)received from the trachea condition sensors. Additionally, oralternatively, the user may insert guide 12 at his/her discretion.

In some embodiments, guide 12 may be configured to movesemi-automatically or automatically. Intubation device 10 may furthercomprise a motion manipulation unit 62 operatively coupled to guide 12and controller 50. Controller 50 may be configured to communicate withtrachea condition sensor 34 and motion manipulation unit 62 viacommunication interface 60 to perform various operations describedherein.

Motion manipulation unit 62 may be configured to cause desired movementsof guide 12 automatically, semi-automatically and/or manually and mayinclude one or more motors, drives, etc. In one example, desiredmovements may include, but are not limited to forward movement, backwardmovement, movements in any direction or any angle relative to a guideposition. The guide's motion may include, but is not limited to linearmotion, 360° rotation or combinations thereof. In some embodiments,guide tip 18 may be configured to perform steering motions, such asmoving in any direction and guide extension 16 is configured to extendand/or retract following guide tip 18. Motion mechanisms to facilitatesuch movement of the guide may include guide actuators, gears, or anysuitable feature or connector that enables the various movementsdescribed herein.

In some embodiments, the guide's movements may be fully automated. Forexample, controller 50 may be configured to include a program or analgorithm to move guide 12 in response to a trachea condition detectedby trachea condition sensor 34. In some embodiments, when guide 12 isinserted into a patient's mouth or nose and intubation device 10 isactivated, guide tip 18 may be automatically moved forward and itsposition may be automatically adjusted in any directions (e.g., 360°degrees) relative to the position of guide 12 to search for or trace thetrachea condition. Guide extension 16 may follow the guide tip 18. As aresult, the guide may appear to perform a snake-like movement. Forexample, guide tip 18 may act like a snake head to steer and lead guide12. Guide extension 16 may perform the snake-like motions and follow theguide tip into the trachea. It should be appreciated that guide 12 maybe configured to perform any suitable movements to search for thetrachea and move into the trachea. Further, it should be noted that anysuitable known method known in the art may be used to enable theautomated movements.

In some embodiments, the guide movements may be performedsemi-automatically. For example, the movements may be actuated throughuser input device 52. User-directed movements such as forward, backward,movements in any direction relative to the guide position may beactuated by a user using corresponding actuators on user input device10.

Additionally, the use-directed movements and/or automated movements maybe guided by information on the trachea condition that is presented ondisplay 54. Alternatively, the movement may be activated or controlledby a user using computing device 90 via a network connections.

Additionally, or alternatively, guide control device 10 may beconfigured to permit the user interaction during the automated orsemi-automated intubation process. For example, the automated guidemovement may be overridden by a user's input at any time. In this way,the intubation may be further refined by the user.

FIG. 5 is a flowchart illustrating an example method 100 to intubate apatient automatically or semi-automatically using an intubation deviceaccording to one embodiment of the present disclosure. First, at 102,method 100 includes activating at least one trachea condition sensors.Next, at 104, method 100 includes moving a guide or introducing theguide. At 106, method 100 determines whether a trachea condition isdetected by a trachea condition sensor. The trachea condition may bedetected when a first trachea condition threshold is exceeded. The firsttrachea condition threshold may be a background level of a tracheacondition around entry points of trachea 24 and esophagus 32. Forexample, where the trachea condition is CO₂, the first threshold may bea CO₂ level at atmosphere. In another example, where the tracheacondition is pressure, the first threshold may be an atmospherepressure. The first threshold may be any suitable value for a specifictrachea condition. Alternatively, the first threshold may be set to zeroby normalizing a background level.

If the trachea condition is not detected by the trachea condition sensor(i.e., the level of the trachea condition is not above the first tracheacondition threshold), then at 108, method 100 includes adjusting thedirection of the guide. As described above, in some embodiments,adjusting the direction of the guide may be accomplished by moving aguide tip in any direction or any angle relative to a guide position ora moving path. Further, the adjustment may be performed while the guideis moved forward into the trachea. Alternatively, the guide may beretracted and redirected from a position where the trachea condition isnot detected. The adjustment may continue until the trachea condition isdetected.

If the trachea condition is detected by the trachea condition sensor(i.e., the level of the trachea condition is above the first tracheacondition threshold), then at 110, method 100 includes moving the guidetoward the trachea condition. In some circumstances, indicia or signalsfor the trachea condition are greater in the lungs and trachea 24 thanthose around an entry point to the trachea. Thus, in some embodiments,the guide may be moved forward in a direction that has an increasedgradient or a higher level of trachea signal or indicia for the tracheacondition. For example, the guide may be moved toward a higher level ofCO₂, higher concentration of an introduced compound, higher air flowrate, or greater energy intensity, etc. However, in some embodiments,the guide may be moved toward a decreased gradient of the tracheacondition. For example, the guide may be moved toward a decreasedpressure or a negative pressure when the trachea condition is airpressure and the patient is taking a deep breath.

Next, at 112, method 100 determines whether the indicia or level of thedetected trachea condition is greater than a second trachea conditionthreshold and/or remains a constant or in a constant range for apredetermined time interval. Since the trachea condition is a uniqueidentifier for trachea 24, indicia for the trachea condition may be in asubstantially constant level in trachea 24. Step 112 may determinewhether the guide tip is positioned in trachea 24.

If the indicia of the trachea condition are greater than the secondtrachea condition threshold and/or consistent for a predetermined timeinterval, at 114, method 100 includes stopping guide movement. Then,endotracheal tube may be slipped over the guide and inserted into thetrachea at 116.

The method described above enables an automatic or semi-automaticmovement of the guide in response to the trachea condition detected bythe trachea condition sensor. Thus, the position of the guide iscontinually adjusted through feedback from the trachea condition sensor.In this way, the guide can be accurately inserted into trachea 24.

Note that various steps or functions illustrated may be performed in thesequence illustrated, in parallel, or in some cases omitted. Likewise,the order of processing is not necessarily required to achieve thefeatures and advantages of the example embodiments described herein, butis provided for ease of illustration and description. One or more of theillustrated steps or functions may be repeatedly performed depending onthe particular strategy being used. Further, the described steps maygraphically represent code to be programmed into the computer readablestorage medium in guide control device.

FIG. 6 is a schematic illustration of an example user interface of anembodiment of an intubation device 10 according to the presentdisclosure. As shown in FIG. 6, a user interface 40 may include a userinput device 52 and a display 54. In some embodiments, user input device52 may include actuators 70 (such as a button, switch, etc.) to activatean operation of intubation device 10. For example, actuators 70 mayselectively activate a trachea condition sensor for a manually-operatedintubation device. In another example, actuators 70 may activate anautomated or semi-automated intubation process. Further, actuators 70may be configured to select proper operating mode or operatingparameters. Additionally, actuators 70 may be configured to override anautomated operation at the user's discretion such that the user maycontrol the intubation due to some unexpected medical conditions.

Additionally, or alternatively, user input device 52 may includeactuators 72 to enable various movements of guide 12 as described above.For example, actuators 72 may actuate and control movements, such asforward movement (FW), backward movement (BW), or movement in anydirection (i.e., any direction in three-dimensional space).

It will be appreciated that the actuators described above may be eithersoft buttons displayed on the graphical user interface of the guidecontrol device 14, or hard controls physically located on the device,such as buttons, joystick, trackball, touch-sensitive pad, etc.Alternatively, it will be appreciated that touch sensitive screen havingtouch selectors may be employed as described above, and/or a non-touchsensitive screen may be utilized and a user input device such as mouseor keyboard may be used to input data and/or actuate buttons.

User interface 40 may also include a display 54 to present informationon the operation of intubation device 10. In one example, informationmay include the trachea conditions detected by the trachea conditionssensors. For example, display 54 may present a level of a tracheacondition presented in either graphic or text format 74 as shown in FIG.6. Further, display 54 may show status of the operation. For example,display 54 may show a message indicating that trachea condition isdetected, or a message indicating that guide is in the trachea. Display54 may present any suitable information to assist the user to operateintubation device 10.

Additionally, or alternatively, user interface 40 may include an imagedisplay 76 to present an image captured by a video disposed on the guidetip. In one example, the image may be a view around the entry point tothe trachea. In another example, the image may relay real time movementof the guide during intubation. The intubation process can be captured,stored and printed according to a user's discretion.

Additionally, or alternatively, in some embodiments where intubationdevice 10 is connected to a network, user interface 40 may include amessage display 78 configured to present a message received from thenetwork. In one example, information may include an instruction on howto operate the intubation device or intubate the patient.

FIG. 7 is a schematic illustration of guide motions in response todetected trachea conditions. As shown in FIG. 7, guide tip 18 may movetoward the trachea condition 80. Guide tip 18 may move in any directionas indicated by x, y, z ordinates. Further, guide tip 18 may move at anyangle, such as α or β and guide extension 16 may move forward and/orretract following the lead of guide tip 18 automatically or based on theuser's inputs or instructions.

The system and methods of the present disclosure may make intubationeasy, fast, and accurate. For example, intubation may be performed basedon a real time trachea condition detected by a trachea condition sensorusing an intubation device. Thus, the trachea can be located accurately.The intubation device may be suitable for both routine and difficultintubations. Further, since the trachea is detected by the tracheacondition sensor, the intubation can be performed without solely relyingon visual observation. Moreover, the intubation device may be suitablefor some difficult intubations where visual verification of insertion orplacement of the endotracheal tube or guide to the endotracheal tube isnot possible.

In some embodiments, the intubation device can be automated based oninformation from the trachea condition sensor. The automation enablescontrolled guide movements. For example, the guide's movement, such as adistance of every move, speed, or moving direction may be programmed todesired values. Thus, insertion may be performed in a smooth andcontrolled manner and may be completed accurately in a short period oftime.

In addition to reduce potential errors in intubation, the intubationdevice also enables easier intubation. Thus, intubation may besuccessfully performed as a life-saving procedure in a variety ofsettings, including emergency sites and battlefields where highlytrained medical professionals may not be available.

FIG. 8 is an exploded front view of a guide tip of an intubation device200 according to another embodiment of the present disclosure. Similarto the intubation device described above, intubation device 200 mayinclude a guide tip 218 and a guide control device. In the depictedembodiments, a plurality of trachea conditions sensors 234 a, 234 b, and234 c are disposed on an end of guide tip 218. The trachea conditionsensors may be different types of sensors to detect different types oftrachea conditions. For example, sensor 234 a may detect an existingtrachea condition sensor 234 b may detect an introduced tracheacondition, and sensor 234 c may detect a signal trachea condition. Anynumber and combination of sensor types are possible and contemplated inthe present disclosure.

Optionally, or additionally, a position sensor 250 may be disposed onguide tip 218 to determine a position of guide tip 218 as a guide movestoward and inside the trachea. Information from position sensor 250 maybe used by the guide control device to adjust movements of the guide toprovide feedback control of the guide tip. Position sensor 250 may beany suitable sensor such as a string potentiometer or a hall effectsensor. In one example, position sensor 250 may be used as a measuringdevice.

The guide may be of any conformation. For example, as shown in FIG. 8,the guide may include a conduit or delivery conduit, such as in a formof a hollow tube with channel 252 that allows the delivery of medicine,inhalation anesthetics, oxygen, the passage for surgical instruments(such as biopsy cable), laser fiber, or suction. Further, the guide mayinclude cords or cables as described in detail in regards to FIG. 9.Moreover, the guide may provide a link for fiber optic cables, etc.

Additionally, intubation device 200 may include a visual assist toverify or confirm the insertion of the guide. In one example, the visualassist may include a video camera 246 and a light source 248 disposed onguide tip 218. Light source 248 may generate light for capture of animage by video camera 246 and light may be transmitted via fiber opticsby a light generate source. The visual assist allows the capture ofimages in a view of the guide tip. In some embodiments, the view mayinclude a view in front of guide tip 218, a view surrounding guide tip218 and a view of guide movements.

The additional video feature allows the insertion to be viewed by theuser to monitor and verify the insertion. Thus, in some embodiments, auser may be able to more easily control the insertion process byobserving the guide tip passing through the vocal cord, moving into thetrachea, and inserting into a targeted body part.

Optionally, in some embodiments, intubation device 200 may be connectedto a network. As described above, connection of intubation device 200with a network enables communications on intubation process orintubation data between the intubation device and a computing deviceconnected to the network. The additional video feature further permitscommunications on captured images or intubation images. The intubationdata and intubation images may be displayed on the computing device sothat the insertion may be viewed, operated, controlled, and/ormanipulated by a third party.

FIG. 9 shows a schematic view of a guide of an intubation device 300according to another embodiment of the present disclosure. Guide 312 mayinclude a guide extension 316 and a guide tip 318. Guide 312 may alsoinclude trachea condition sensors 334 a, 334 b, and 334 c. In thedepicted embodiment, trachea sensors 334 a and 334 b are disposed on anend of guide tip 318. Trachea sensor 334 c is disposed adjacent to guidetip 318 and spatially apart from guide tip 318.

Guide 312 may assume various configurations to facilitate automaticmovements based on specific motion mechanisms. For example, guide 312may include one of the features illustrated at A, B, and C. In someembodiments, guide 312 may comprise an extendable section or retractablesection A. In some embodiments, guide 312 may include a section B havingindividual segments 360. Individual segments 360 may be operativelycoupled together to provide certain degree of rigidity and flexibilityto facilitate desired movements. In some embodiments, guide 312 mayinclude a section C having a plurality of disks 362 connected by aplurality of cords 364. Again, section C may enable and facilitatedesired movements. Although four cords are shown in FIG. 9, it should benoted that any number of cords may be used.

The features described above may enable a snake-like movement of theguide. It should be noted that any one of the sections A, B, and C mayextend only a portion of the guide or may extend a substantial length ofthe guide. Alternatively, guide 312 may include one or more of thesections A, B, C, or other motion enabling section or guide 312 mayinclude any combination of section A, B, C, or other motion enablingsections.

Also shown in FIG. 9, a coupler 368 is configured to couple guide 312 tothe guide control device mechanically and electrically. In someembodiments, guide 312 may be detachably coupled to guide control deviceso that guide 312 may be changed to suit for requirements for differentpatients.

FIG. 10 illustrates another embodiment of an intubation device 400according to the present disclosure. An exploded front view of a guidetip 418 of intubation device 400 is shown in FIG. 11. It should beappreciated that intubation device 400 may be used for various medicalprocedures in addition to intubation. In some embodiments, intubationdevice 400 may be used to assist a medical procedure such as delivery ofmedicine, etc. In other embodiments, intubation device 400 may perform amedical procedure by an insertion of a medical instrument 456 into apatient's body via a patient's trachea.

As shown in FIG. 10, intubation device 400 may include a guide 412 and aguide control device 414. Guide control device 414 may include a userinterface 440. As shown in FIG. 11, intubation device 400 may alsoinclude trachea condition sensors 434 a and 434 b. As described above,trachea condition sensor may detect an existing trachea condition, anintroduced trachea condition, or a signal trachea condition. Intubationdevice 400 may enable an insertion of guide 412 based on tracheacondition detected by trachea condition sensors 434 a and 434 b.

Intubation device 400 may also include a multiple functional port 442.In some embodiments, multiple functional port 442 may be configured toadministrate medicines to the patient. In some embodiments, multiplefunctional port 442 may be used as an entry to insert medical instrument456 into guide 412. It should be noted that multiple functional port 442may be positioned at any suitable location of intubation device 400.

As shown in FIG. 11, intubation device 400 may also include a conduit458. In some embodiments, the hollow tube of guide 412 may be used asconduit 458. In some embodiments, conduit 458 may be used to delivermedicine. In some embodiments, conduit 458 may be used as a passage formedical instrument 456. Medical instrument 456 attached to a cable or aconnector 460 may be positioned into conduit 458 through multiplefunctional port 442. Medical instrument 456 may be used to performvarious medical procedures, such as a tissue biopsy, laser treatment,diagnostic procedure, therapeutic procedure, etc.

It should be appreciated that conduit 456 may be a separate tube coupledto guide 412. Further, it should be noted that a plurality of conduitsmay be coupled to guide 412 for particular medical procedures.

Additionally, in some embodiments, intubation device 400 may include avisual assist to verify or confirm the insertion of guide 412. In oneexample, the visual assist may include an image capture device 446, suchas a video camera, or a still camera. The visual assist may furtherinclude a light source 448 to provide light for image capture device446. In the depicted embodiment, video camera 446 and light source 448are disposed on guide tip 418 and adjacent to each other. Light may betransmitted to light source 448 through a light generation source 450.Light source 448 and light generation source 450 may include anysuitable light producing device, such as fiber optics.

The visual assist allows an image in a view of guide tip 418 and guidemovements to be captured by video camera 446. A video attachment 452 andan eye piece 454 may be included to allow the user to view the capturedimages.

Optionally, in some embodiments, intubation device 400 may be connectedto a network such that intubation data and intubation images may bedisplayed on a computing device connected to the network. In this way,the insertion may be viewed, operated, controlled, and/or manipulated bya third party.

It will be appreciated that the configurations and routines disclosedherein are exemplary in nature, and that these specific embodiments arenot to be considered in a limiting sense, because numerous variationsare possible. The subject matter of the present disclosure includes allnovel and nonobvious combinations and subcombinations of the varioussystems and configurations, and other features, functions, and/orproperties disclosed herein.

The following claims particularly point out certain combinations andsubcombinations regarded as novel and nonobvious. These claims may referto “an” element or “a first” element or the equivalent thereof Suchclaims should be understood to include incorporation of one or more suchelements, neither requiring nor excluding two or more such elements.Other combinations and subcombinations of the disclosed features,functions, elements, and/or properties may be claimed through amendmentof the present claims or through presentation of new claims in this or arelated application. Such claims, whether broader, narrower, equal, ordifferent in scope to the original claims, also are regarded as includedwithin the subject matter of the present disclosure.

1. An intubation device, comprising: a movable guide configured to guide an insertion of an endotracheal tube into a trachea of a patient, the guide having a guide extension and a guide tip; an external trachea identifier source external to the trachea and disposed on the patient during an intubation, wherein the trachea identifier source generates and transmits a signal; at least one trachea condition sensor disposed on the guide tip to detect the signal generated by the trachea identifier source; and a guide control device operatively coupled to the guide, the guide control device configured to move the guide into the trachea in response to the detected signal.
 2. The intubation device of claim 1, wherein the trachea identifier source is an invisible light source or a visible light source, and the trachea condition sensor is a light sensor to detect light from the invisible light source or the visible light source.
 3. The intubation device of claim 1, wherein the trachea identifier source is a sound generating source or an ultrasound generating source and the trachea condition sensor is a sound detector.
 4. The intubation device of claim 1, wherein the trachea identifier source is one of a magnetic source and an electrical source, and the trachea condition sensor is one of a magnetic sensor and a meter to measure a voltage or a current.
 5. The intubation device of claim 1, wherein the guide control device further comprises: a motion manipulation unit to move the guide; and a controller to communicate with the trachea condition sensor and the motion manipulation unit; wherein the guide is moved automatically by the motion manipulation unit via execution of a software program stored in the controller.
 6. The intubation device of claim 1, wherein the guide control device further comprises: a user input device; a motion manipulation unit to move the guide; and a controller to communicate with the user input device, the trachea condition sensor, and the motion manipulation unit; wherein the guide is moved by activation of the user input device.
 7. The intubation device of claim 1, further comprising a video camera disposed on the guide tip to capture images of openings of the trachea and the esophagus to monitor an insertion of the guide, wherein the external trachea identifier is disposed on a front neck of the patient during the intubation.
 8. An intubation device, comprising: a movable guide configured to guide an insertion of an endotracheal tube into a trachea of a patient, the movable guide having a guide extension and a guide tip; an external trachea identifier source disposed external to the trachea and on a body of the patient during an intubation, wherein the trachea identifier source generates a signal and transmits the signal toward the trachea; at least one trachea condition sensor disposed on the guide tip to detect the signal generated and transmitted by the trachea identifier source; and a guide control device operatively coupled to the guide and communicatively linked to the trachea condition sensor, the guide control device configured to process a detected signal from the trachea condition sensor to determine an opening of the trachea and direct an insertion of the guide into the trachea in response to the detected signal.
 9. The intubation device of claim 8, wherein the opening of the trachea is determined based on a pattern of the detected signal.
 10. The intubation device of claim 8, wherein the opening of the trachea is determined based on an intensity or a level of the detected signal.
 11. The intubation device of claim 8, further comprising a position sensor disposed on the guide tip, wherein the position sensor determines a position of the guide tip and provides feedback control to the guide control device.
 12. The intubation device of claim 8, further comprising a video camera disposed on the guide tip to capture images of an opening of the trachea and an opening of an esophagus of the patient to monitor the insertion of the guide into the trachea.
 13. The intubation device of claim 8, wherein the trachea identifier source is an invisible light source or a visible light source, and the trachea condition sensor is a light sensor to detect light from the invisible light source or the visible light source.
 14. The intubation device of claim 8, wherein the trachea identifier source is a sound generating source or an ultrasound generating source and the trachea condition sensor is a sound detector.
 15. The intubation device of claim 8, wherein the trachea identifier source is one of a magnetic source and an electrical source, and the trachea condition sensor is one of a magnetic sensor and a meter to measure a voltage or a current.
 16. The intubation device of claim 8, wherein the trachea identifier source is mounted on a needle-like structure and embedded into a front neck of the patient during the intubation.
 17. The intubation device of claim 8, wherein the guide control device includes instructions to retract the guide and redirect the guide from a position where processed signal information does not indicate the trachea.
 18. The intubation device of claim 8, further comprising at least one conduit coupled to the guide wherein the conduit delivers medicine or performs one of a tissue biopsy, a laser treatment, a diagnostic procedure, and a therapeutic procedure.
 19. A method of intubating a patient using an intubation device, the intubation device including a guide, at least one trachea condition sensor on a tip of the guide, and a guide control device configured to move the guide, the method comprising: disposing an external trachea identifier source in a location external to a trachea of the patient; detecting signals transmitted from the external trachea identifier source using the trachea condition sensor; processing real time information from the detected signal of the trachea condition sensor to determine an opening of the trachea; and moving the guide in response to the processed real time information.
 20. The method of claim 19, wherein processing the information includes analyzing an intensity or a pattern of the detected signals, and moving the guide in response to the processed information includes moving the guide toward the opening of the trachea indicated by the processed information.
 21. The method of claim 19, wherein the intubation device further includes an image capture device disposed on the tip of the guide to capture an image as the guide moves, the method further comprising confirming that the guide is inserted into the opening of the trachea based on the captured image. 